Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Open Public Meeting December 14-15, 2006 - PowerPoint PPT Presentation

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Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Open Public Meeting December 14-15, 2006

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There are not enough safe and effective antibiotics ... pharma greed for. drugs for simple infections. Risk-Benefit? WHERE ARE THE MAGIC BULLETS? ... – PowerPoint PPT presentation

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Title: Joint Meeting of the Anti-Infective Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Open Public Meeting December 14-15, 2006


1
Joint Meeting of the Anti-Infective Drugs
Advisory Committee and the Drug Safety and Risk
Management Advisory CommitteeOpen Public
MeetingDecember 14-15, 2006
  • Prabhavathi Fernandes, Ph.D.
  • President and CEO
  • Cempra Pharmaceuticals, Inc.
  • prabha_at_fernandes-domain.com

2
All of Us Have the Same Goals
We all want affordable antibiotics -that are safe
and effective against resistant bacteria
Patients
Physicians
Pharma Biotech
FDA
Success REQUIRES that we are all on the same
tablet !
3
The Tablet is Broken

Lack of clear guidelines to develop
antibacterials makes the financial risk too high
Pharma Biotech
The return on investment is too low
Patients
There are not enough safe and effective
antibiotics
FDA
We need extraordinarily safe antibiotics that
are more effective than placebo
Physicians
4
Using Ketek as an Example - Find the Cause of
the Problem
Antibiotics developed used for serious
infections
Antibiotics safe effective
Patients demand for antibiotics for simple
infections
Pharma Success
1975
1940
FDA, patients Congress question use and safety
of antibiotics
Physician Patient comfort
WHERE ARE THE MAGIC BULLETS?
Increased profits from antibiotic sales for
simple infections
2005
1985
Millions of patients exposed
Increased patient exposure increased reporting
of adverse effects
Risk-Benefit?
Patient demand and pharma greed for drugs for
simple infections
Pharma markets aggressively for simple infections
5
Thoughts that Have Arisen After Ketek was
Approved
  • Should wide-spread use be discouraged to prevent
    selection of resistant bacteria?
  • We are killing the goose that is laying the
    golden eggs
  • Should FDA protect public from unnecessary
    exposure to antibiotics that can result in harm?
  • Should patients be using so many antibiotics for
    simple infections?
  • Should physicians be writing so many antibiotic
    prescriptions?
  • Should pharma sales reps promote antibiotics for
    simple infections?

6
Unrealistic Expectations
  • No drug (or antibiotic) is completely safe
  • Risk-benefit analysis is easier when treating
    serious infections
  • It is impossible to detect every rare side effect
    in any-size trials- no point in increasing the
    clinical trial size
  • Need pre-clinical toxicology, clinical safety in
    1000 patients
  • Need mandatory submission of Phase IV data
  • Ban on promotion for simple infections
  • Waiting to get sufficient patients with resistant
    bacterial infections to prove efficacy in
    clinical trials is like waiting until a house is
    on fire to buy insurance!

7
Proposal for Clinical Trial Design to
Demonstrate Efficacy
  • For simple infections, placebo controlled trials
    are the only way to demonstrate that a drug is
    effective
  • Comparator controlled trials should be used for
    serious or complicated infections to demonstrate
    efficacy
  • 200 cases tested with new drug vs. one of the TOP
    two standard-of-care antibiotics
  • Non inferiority to these compounds should be
    approved
  • Approval for organ system of infection (e.g.
    Respiratory, SSSI)
  • In infectious diseases, the biomarker is
    isolation of the pathogen demonstrate the
    pathogen and clearance
  • A new antibiotic that has activity in vitro and
    in animal model against resistant bacteria, and
    has equal or even less activity as comparator
    antibiotics in clinical trials, should be
    approved for treating resistant bacteria

8
Encouragement for Developing New Antibiotics
  • Clear FDA guidelines to make drug development
    feasible
  • Two adequate (400 patients each) and comparator
    controlled, non-inferiority studies for serious
    infections
  • Approval on the ORGAN SYSTEM basis to decrease
    costs of multiple clinical trials
  • Some diseases are rare (e.g. endocarditis) and
    guidelines could combine many rare, deep
    tissue/organ infections into one claim
  • Government should provide incentives to small
    companies who are addressing public health needs
    for new antibiotics eg. matching grants,
    development expense refunds, tax incentives etc.
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